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New treatment option for High Grade Sarcoma
Official title Habitat Escalated Adaptive Therapy (HEAT), With Neoadjuvant Radiation for Soft Tissue Sarcoma
ClinicalTrials.gov ID: NCT05301283
What this study is testing
- What it's testing
- The purpose of the study is to utilize radiomic images to precisely locate areas of tumor that can be treated with dose escalation radiation therapy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- For women of childbearing potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method...
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner 52 weeks after radiation.
- Agreement to adhere to Lifestyle Considerations (as outlined in protocol) throughout study duration.
You likely can't join if
- Contraindications to an MRI
- Positive urine pregnancy test
- Gross total excision of primary STS, including an unplanned excision
- Superficial sarcoma located primarily in the subcutaneous or cutaneous tissue
- Prior radiation to the region of the study cancer that would result in overlap of radiation therapy fields.
- Participants with a medical condition or social situation that, at the discretion of the principal investigator, would preclude them from completion...
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- For women of childbearing potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 52 weeks after the...
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner 52 weeks after radiation.
- Agreement to adhere to Lifestyle Considerations (as outlined in protocol) throughout study duration.
- Pathologically (histologically or cytologically) proven diagnosis of high-grade (grade 2 or 3) Soft Tissue Sarcoma (STS) of the deep trunk and/or extremity. Clinical evidence should be documented, and may consist of...
- Primary site deemed resectable prior to the start of trial
- American Joint Committee on Cancer (AJCC) 8th edition staging T1-4 N0 M0, no evidence of distant metastases
- Patients must have clinically or radiographically evident measurable disease at the primary site.
- Pre-Radiation Therapy (RT) MRI within 4 weeks of the start of RT.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 3.
- Deemed a surgical candidate
- Participant agrees to blood and plasma preservation for future analysis.
- Contraindications to an MRI
- Positive urine pregnancy test
- Gross total excision of primary STS, including an unplanned excision
- Superficial sarcoma located primarily in the subcutaneous or cutaneous tissue
- Prior radiation to the region of the study cancer that would result in overlap of radiation therapy fields.
- Participants with a medical condition or social situation that, at the discretion of the principal investigator, would preclude them from completion of the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.